Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer

Stopped early · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

Key facts

Study ID

NCT00701870

Run by

Telik

People needed

1

Starts

2008-10-01

Expected to finish

2008-11-01

Last updated by the study team

2013-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed NSCLC
• Stage IIIb-Stage IV NSCLC
• ECOG performance status of 0-2
• Adequate liver and renal function
• Adequate bone marrow reserve

You may not qualify if…

• Treatment with neoadjuvant or adjuvant chemotherapy within 1 year
• Histologically confirmed mixed tumors containing small cell elements
• Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
• History of bone marrow transplantation or stem cell support
• Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants
• History of HIV
• Grade 3 or 4 peripheral neuropathy
• Weightloss greater than 5% within 6 months
• Uncontrolled pleural effusion

Where it is running

• Central Hematology Oncology Medical Group — Alhambra, California, United States
• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• Providence St. Joseph Medical Center — Burbank, California, United States
• St. Jude Heritage Healthcare — Fullerton, California, United States
• Wilshire Oncology Medical Group — La Verne, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Clinical Trials and Research Associates, Inc. — Montebello, California, United States
• North Valley Hematology/Oncology Medical Group — Northridge, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Samsum Clinic — Santa Barbara, California, United States
• Santa Barbara Hematology Oncology Medical Group, Inc. — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Broward Oncology Associates — Fort Lauderdale, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• Florida Hospital Cancer Institute — Ormand Beach, Florida, United States
• Suburban Hematology-Oncology Associates, PC — Lawrenceville, Georgia, United States
• Medical & Surgical Specialists — Galesburg, Illinois, United States
• Joliet Oncology/Hematology Associates, Ltd. — Joliet, Illinois, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Case Medical Center-University Hospitals — Cleveland, Ohio, United States
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Coastal Cancer Center — Myrtle Beach, South Carolina, United States

Full record on ClinicalTrials.gov

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